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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06430827
Other study ID # CSPC-DNY-BTC-02
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date June 30, 2024
Est. completion date December 31, 2025

Study information

Verified date May 2024
Source Peking Union Medical College Hospital
Contact Yi Ba, PHD
Phone +86 010 69158705
Email bayipumch@aliyun.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the efficacy and safety of irinotecan hydrochloride liposome injection combined with Capecitabine for second-line treatment in Patients With advanced or metastatic biliary tract carcinoma.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date December 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. The patient had good compliance, could understand the research process of this study, and signed a written informed consent. 2. Age =18 years. 3. Has histologically confirmed diagnosis of advanced (metastatic) and/or unresectable (locally advanced) biliary tract cancer (intra-or extrahepatic cholangiocarcinoma or gallbladder cancer). 4. Subjects who had received gemcitabine prior first-line therapy and had not received fluorouracil drugs. 5. Subjects who have progressed after receiving previous first-line therapy, relapse within 6 months after the end of (neo) adjuvant therapy is considered as first-line therapy failure. 6. Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1). 7. ECOG (Eastern Cooperative Oncology Group) performance status of 0-2. 8. Has a life expectancy of greater than 3 months. 9. LVEF=50%. 10. Appropriate organ function is defined as follows: (Hematology and blood biochemistry tests must be completed within 14 days prior to enrollment, and the following criteria are met): 1. ANC =1.5×10^9/L 2. Hb=90g/L 3. PLT =100×10^9/L 4. total bilirubin =1.5 x ULN 5. ALT/AST = 2.5 x ULN; When there is liver metastasis, ALT/AST = 5 x ULN 6. Serum creatinine (Cr) =1.5×ULN or creatinine clearance (CCr) =50mL/min (according to Cockcroft-Gault fórmula) 7. Coagulation function: prothrombin time (PT), activated partial thromboplastin time (APTT) and international standardized ratio (INR) =1.5×ULN 11. Patients with biliary obstruction should receive adequate biliary drainage. 12. Adverse reactions caused by previous treatment must be restored to grade 1 or baseline according to CTCAE5.0 (except for toxicity such as alopecias, grade 2 and below peripheral neuropathy, which can be included after the investigator determines that there is no safety risk). 13. non-pregnant or lactating female; Effective contraception should be used by female/Male of childbearing age during the study period and for 6 months after the end of study treatment. 14. There were no contraindications for the use of irinotecan liposomes and capecitabine. Exclusion Criteria: 1. Patients who have had other malignant tumors within the previous 5 years (except cured carcinoma in situ and skin basal cell carcinoma). 2. Uncontrolled pleural effusion or ascites. 3. Any known brain or meningeal metastases. 4. Subjects were co-administering a potent CYP3A4 inducer within 3 weeks prior to first dosing, or a potent CYP3A4 inhibitor or a potent UGT1A1 inhibitor within 3 weeks prior to first dosing. 5. Subjects underwent large organ surgery (except needle biopsy, central venous catheterization, port catheterization, stenting for relief of biliary obstruction, percutaneous hepatobiliary drainage, and cholecystostomy) or an elective surgical program within 4 weeks before the first dose of the study drug. 6. Active, uncontrolled bacterial, viral, or fungal infections with systemic treatment, defined as persistent signs/symptoms associated with infection that do not go away despite the use of appropriate antibiotics, antiviral therapy, and/or other treatment, including patients with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV). 7. Patients who are known to have dihydropyridine dehydrogenase (low activity) or deficiency. 8. There are serious concomitant diseases: such as uncontrolled diabetes after hypoglycemic drug treatment, uncontrolled hypertension, serious cardiovascular and cerebrovascular disease, kidney failure, liver failure, uncontrolled epilepsy, central nervous system disease or mental disorder history, clear gastrointestinal bleeding tendency, intestinal paralysis, intestinal obstruction, etc. 9. Grade 1 diarrhea with an increase in the number of stools > 4 times per day compared to baseline; The moderate and severe effluents from stoma increased; Limited activities of daily living with the aid of tools or even self-rational activities of daily living; Life-threatening; Need urgent medical attention. 10. Had participated in other clinical investigators within 4 weeks before enrollment. 11. Unsuitable for participation in the trial by the investigator assessed.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
irinotecan hydrochloride liposome injection
rinotecan hydrochloride liposome injection (70mg/m^2) will be administered by intravenous infusion on day 1 in a 2-week treatment cycle.
Capecitabine
Capecitabine (1000 mg/m^2) will be administered orally in a 2-week treatment cycle, twice a day from day 1 to day 10 of each cycle

Locations

Country Name City State
China Peking Union Medicalcollege Hospital Beijing

Sponsors (2)

Lead Sponsor Collaborator
Ba Yi CSPC Ouyi Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression-free survival (PFS) To evaluate the efficacy of anti-tumor baseline up to approximately 6 months
Secondary Objective response rate (ORR) To evaluate the efficacy of anti-tumor baseline up to approximately 6 months
Secondary Overall survival (OS) To evaluate the efficacy of anti-tumor baseline up to approximately 12 months
Secondary Quality of life (QoL) To identify the quality of life by QLQ-C30(V3.0) baseline up to approximately 12 months
See also
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Active, not recruiting NCT04003636 - Pembrolizumab (MK-3475) Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin for First-Line Advanced and/or Unresectable Biliary Tract Carcinoma (BTC) (MK-3475-966/KEYNOTE-966) Phase 3
Not yet recruiting NCT05064852 - A Real-world Study of the Safety and Efficacy of Surufatinib in the Treatment of Biliary Tract Carcinoma
Recruiting NCT05668884 - GEMOX Combined With Donafenib and Tislelizumab in Advanced Biliary Tract Carcinoma Phase 2
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Active, not recruiting NCT04924062 - Pembrolizumab (MK-3475) Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin for First-Line Advanced and/or Unresectable Biliary Tract Carcinoma (BTC) (MK-3475-966/KEYNOTE-966)-China Extension Study Phase 3
Not yet recruiting NCT06463548 - Irinotecan Hydrochloride Liposome Combined With Capecitabine and Lenvatinib in Patients With Biliary Tract Carcinoma N/A
Terminated NCT04178460 - A Study of Niraparib Combined With MGD013 in Patients With Advanced or Metastatic Solid Tumor Who Failed Prior Treatment Phase 1
Completed NCT03027284 - A Study of Merestinib (LY2801653) in Japanese Participants With Advanced or Metastatic Cancer Phase 1
Recruiting NCT06199882 - SBRT Sequential Surufatinib Combined With Immunotherapy for Biliary Tract Carcinoma Phase 2
Active, not recruiting NCT05023109 - GP Chemotherapy in Combination With Anti-PD-1 and Anti-TIGIT in Unresectable Advanced BTC Phase 2
Not yet recruiting NCT06168292 - Intraductal Radiofrequency Thermoablation and Radiotherapy Combined Treatment for Extrahepatic Cholangiocarcinoma N/A
Recruiting NCT04979663 - GEMOX Combined With Donafenib and Tislelizumab in Biliary Tract Cancer Phase 1/Phase 2